LungLB(TM) will be the first cell-based non-invasive, blood test to rule-out patients with indeterminate lung nodules from having cancer. Over 20,000 patients per year in the United States receive an indeterminate diagnosis following CT scan and face prospect of surgery.
WESTLAKE VILLAGE, CA – April 11, 2018 – MD Anderson and Cynvenio Biosystems, Inc. today announced the beginning of the final clinical validation phase of Cynvenio LungLB(TM). LungLB(TM) definitively answers whether patients with indeterminate lung nodules have cancer or not from a simple blood draw. The MD Anderson led study continues on successful data achieved on LungLB(TM) showing a sensitivity of 91% and specificity of 93% in patients with indeterminate lung nodules who are candidates for biopsy.
“LungLB(TM) has the potential to provide clarity for a large number of patients where we see a nodule on a CT scan, but it’s not clear whether or not there is cancer,” said Joshua Kuban, M.D., assistant professor of interventional radiology MD Anderson and lead investigator. “This is a critical issue in the front-end management of lung cancer that creates considerable patient anxiety and where the surgical procedure is not without risk.”
“I have myself had several failed biopsies and had to put off treatment for a month,” shares Bonnie Addario, lung cancer survivor, Founder and Chair, Bonnie J. Addario Lung Cancer Foundation. “A blood test to determine whether small nodules are malignant or not can prevent months of putting your life ‘on hold’ and needless worry.”
The current standard for early lung cancer detection is subject to a high false positive rate that ultimately results in thousands of unnecessary invasive and dangerous biopsies being performed each year. Cynvenio’s LungLB(TM) test is designed to confirm the presence of cancer in patients with indeterminate lung nodules following low-dose CT, as studies have shown that nearly half of patients who receive biopsy following identification of a suspicious nodule do not have lung cancer†.
Studies have shown significant and lasting psychological impact to patients following negative biopsy. In addition to using the test as a risk-stratification tool, Cynvenio is determined to identify the utility of the test as a monitoring tool for these patients to provide peace of mind between scans.
The Cynvenio LiquidBiopsy® platform has many features unique to the field of circulating tumor cells including the ability to get a pure eluate of positively selected cells for advanced single cell and NGS testing. The platform has now been adapted to run the LungLB(TM) test and is teamed with an advanced cytoinformatics capability to reduce analysis times.
LungLB(TM) is currently being implemented by Cynvenio’s Joint Venture in China, Cynvenio-Livzon Diagnostics, on an estimated 3,000 Chinese patients with indeterminate nodules.
NCCN Guidelines now currently recommend considering the use of liquid biopsy in NSCLC patients to assess mutations predictive of response to targeted therapy. With LungLB(TM), clinicians will have another non-invasive tool to obtain information that will help with clinical decision making. Within its CLIA certified CAP-accredited laboratory, Cynvenio provides doctors with comprehensive non-invasive tools for lung cancer spanning early to late stage diagnosis.
For additional information or to order the test, please contact Cynvenio at 888-885-1172.
About Cynvenio Biosystems, Inc.
Cynvenio’s liquid biopsy testing technology is leading the way to more affordable and clinically actionable precision medicine strategies for cancer patients. Among the company’s breakthroughs is its line of ClearID® tests for greatly improved cancer detection and monitoring via a patient-friendly blood draw, and a suite of proprietary, distributable LiquidBiopsy® platforms and consumables for deployment in hospitals and third-party diagnostic labs. Cynvenio is based in Westlake Village, California. For more information, please visit https://www.cynvenio.com/, https://www.clearidmonitoring.com/, and https://www.liquidbiopsy.com/.
LiquidBiopsy® and ClearID® are registered trademarks of Cynvenio Biosystems, Inc.
†Lokhandwala et al. Costs of Diagnostic Assessment for Lung Cancer: A Medicare Claims Analysis (2016)